Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR

K-Number: K904988 · 1991-03-18

ApplicantPalco Laboratories, Inc.
Decision Date1991-03-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Palco Laboratories, Inc.. It received FDA 510(k) clearance on 1991-03-18 under 510(k) number K904988. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR?

PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR is a medical device that received FDA 510(k) clearance on 1991-03-18. The listed applicant is Palco Laboratories, Inc.. The 510(k) number is K904988.

When did PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR receive FDA 510(k) clearance?

PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR received FDA 510(k) clearance on 1991-03-18, under 510(k) number K904988.

Who is the listed applicant for PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR?

The FDA 510(k) record lists Palco Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR?

The FDA product code for PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR is DQA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Palco Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942810PALCO LABS COLD POUCHK943842PULSE OXIMETER MODEL 305K920066PALCO LABS MODEL 340 PULSE OXIMETERK913694PALCO LABS LOADMATICK911191PALCO LABS MODEL 300 OXYGEN/PULSE MONITORK872233INJECT-EASE

View all 9 devices →

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑